Cervavac Gets WHO Prequalification

CERVAVAC, India’s first indigenously developed gender-neutral quadrivalent human papillomavirus (HPV) vaccine, has received prequalification from the World Health Organization (WHO). This paves the way for its procurement by United Nations agencies and potentially expanding access to HPV vaccination globally.

Developed by the Pune-based Serum Institute of India (SII), CERVAVAC protects against four HPV types — 6, 11, 16 and 18. The recombinant vaccine is indicated for girls and boys aged 9 to 26 years and has already been approved for use in India by the Drugs Controller General of India (DCGI).

WHO prequalification is an important step for vaccines seeking to enter international procurement programmes. Products that meet the WHO’s standards for quality, safety and efficacy can be included on its list of prequalified vaccines, allowing UN agencies to procure them for immunisation programmes.

For India, the recognition is also significant because it puts an indigenously developed HPV vaccine in a position to contribute to prevention efforts beyond the country.

HPV is one of the most common sexually transmitted infections, and persistent infection with certain high-risk types can lead to several cancers. HPV vaccination is therefore an important tool in preventing HPV-associated disease, particularly when administered before exposure to the virus.

CERVAVAC targets four HPV types. Types 16 and 18 are among the HPV strains most strongly associated with cancers, while types 6 and 11 are responsible for most cases of genital warts.

The vaccine is indicated for the prevention of diseases caused by these four types. Its indications include prevention of cervical, vulvar, vaginal and anal cancers in girls and young women, as well as anal cancer in boys and young men. It is also indicated for the prevention of genital warts in the applicable age group.

Adar Poonawalla, Chief Executive Officer, SII, said, “WHO prequalification of CERVAVAC is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks."

“We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare.”

The WHO milestone comes at a time when countries are seeking to improve HPV vaccination coverage as part of efforts to reduce the burden of cervical cancer and other HPV-related diseases. While cervical cancer remains a major public-health concern, vaccination, screening and timely treatment together can significantly reduce the disease burden.

The gender-neutral indication is particularly relevant because HPV infection affects both males and females. Vaccinating boys can provide them with direct protection against certain HPV-related diseases and can also contribute to broader prevention of transmission.

For the Serum Institute, the prequalification also adds to its record of WHO-recognised products. CERVAVAC marks the company’s 32nd WHO prequalification for products or biologicals.

WHO prequalification does not replace individual regulatory approval in countries. National authorities continue to determine whether and how a vaccine will be introduced into their immunisation programmes.

For CERVAVAC, however, the listing represents an important transition from an Indian-developed vaccine to one that can potentially support international public-health programmes.

The next challenge will be ensuring that scientific progress translates into wider vaccination coverage, particularly among adolescents and young people who stand to gain the greatest preventive benefit, said an official from the Union Health Ministry.